Warning
Class II
Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt.
cGMP deviations
Blossom Pharmaceuticals
FDA Recalls
Page 23 of 24 · 1,199 total recalls
Recalls — Page 23
Warning
Class II
Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd.
Failed Stability Specifications: Observed OOS results: eg results for colour index
Cipla Limited
Critical
Critical
Class I
POTASSIUM CHLORIDE Inj.
Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM...
Otsuka ICU Medical LLC
Critical
Class I
POTASSIUM CHLORIDE Inj.
Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM...
Otsuka ICU Medical LLC
Warning
Class II
Agebox iKids-Growth (Night Formula)
Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
Agebox
Warning
Class II
Agebox iKids-Growth (Day Formula) capsules
Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
Agebox
Warning
Class II
Lisdexamfetamine Dimesylate Capsules
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at...
SUN PHARMACEUTICAL INDUSTRIES INC
Info
Class III
Multivitamin with Fluoride Chewable Tablets Grape Flavor Rx NDC 75826-169-10 0.25 mg 100 TABLETS UPC 3 15826 16910 2
Subpotent. During an FDA inspection it was discovered that the product was subpotent for Vitamin D.
Winder Laboratories
Warning
Class II
Lanthanum Carbonate chewable tablets
Failed stability specifications: Out of specification for hardness test
Cipla USA
Warning
Class II
Lanthanum Carbonate chewable tablets
Failed stability specifications: Out of specification for hardness test
Cipla USA
Warning
Class II
Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only.
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity...
Zydus Pharmaceuticals (USA) Inc
Warning
Class II
clomiPRAMINE Hydrochloride
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs),...
Zydus Pharmaceuticals (USA) Inc
Warning
Class II
clomiPRAMINE Hydrochloride
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs),...
Zydus Pharmaceuticals (USA) Inc
Warning
Class II
clomiPRAMINE Hydrochloride
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs),...
Zydus Pharmaceuticals (USA) Inc
Critical
Class I
SILINTAN 25/pills
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
ANTHONY TRINH
Warning
Class II
NIACIN Extended-Release Tablets
Failed Dissolution Specifications
Golden State Medical Supply Inc.
Warning
Class II
Acetaminophen 500mg Caffeine 65mg caplets
Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients...
Aero Healthcare
Warning
Class II
Testosterone / Triamcinolone Acetonide 25MG/5MCG
CGMP Deviations: Potential presence of metal particulate matter
FARMAKEIO OUTSOURCING LLC
Warning
Class II
Testosterone 50MG
CGMP Deviations: Potential presence of metal particulate matter
FARMAKEIO OUTSOURCING LLC
Warning
Class II
Testosterone 62.5 MG
CGMP Deviations: Potential presence of metal particulate matter
FARMAKEIO OUTSOURCING LLC
Warning
Class II
Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG)
CGMP Deviations: Potential presence of metal particulate matter
FARMAKEIO OUTSOURCING LLC
Warning
Class II
Amoxicillin and Clavulanate Potassium for Oral Suspension USP
Subpotent drug; Clavulanate Potassium component
Teva Pharmaceuticals USA
Warning
Class II
Haloperidol Lactate Injection
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
Safecor Health
Warning
Warning